Radiation before mastectomy with immediate breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PRADAIIBE is a multicenter, randomized phase III trial enrolling adult women in Belgium who require mastectomy and post‑mastectomy radiation and who want breast reconstruction. After consent and baseline questionnaires and photographs, participants are randomized to either standard care (mastectomy, postoperative radiation, and delayed or immediate reconstruction) or experimental care (preoperative radiation followed by immediate reconstruction). The primary endpoint is breast satisfaction at one year measured by the BREAST‑Q, with secondary endpoints including quality of life scores, aesthetic panel scores, treatment duration, pathological complete response, adverse events, and survival. Centralized randomization and standardized outcome instruments are used to ensure comparability across sites.

Why it matters

Who can join: the full rules

Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.

Inclusion criteria:

In order to be eligible to participate in this study, a participant must meet all of the following criteria:

1\. Women ≥18 years with histopathologically confirmed breast cancer who:

1.a. require SSM/NSM for any reason (e.g. extensive disease)

1.b. require postoperative radiation therapy of at least the chest wall

1. c. have a wish for a breast reconstruction
2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.

Exclusion criteria:

A potential participant who meets any of the following criteria will be excluded from participation in this study:

1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed.
2. Collagen synthesis disease
3. Ongoing pregnancy
4. Actively breastfeeding
5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \>3months preoperatively.
6. BMI \> 35 kg/m2
7. cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated

Where it's running

• Universitair Ziekenhuis Antwerpen (UZA)
  Edegem, Antwerpen, Belgium Recruiting
• Ziekenhuis aan de stroom
  Wilrijk, Antwerpen, Belgium Recruiting
• CHU Namur
  Namur, Namur, Belgium Recruiting
• AZ Groeninge
  Kortrijk, West Vlaanderen, Belgium Recruiting
• AZ Klina
  Brasschaat, Antwerp, Belgium Not yet recruiting
• Universitair Ziekenhuis Gent (UZGent)
  Ghent, Oost Vlaanderen, Belgium Not yet recruiting

Study contacts

• Principal investigator: Melanie Machiels, MD, PhD — Iridium netwerk
• Study coordinator: Tom Quisenaerts, MD
• Email: Tom.quisenaerts@zas.be
• Phone: +3234433759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.